SARS-CoV-2（COVID19）大流行对接受手术的高危患者发病率和死亡率的影响：一项非劣效性回顾性观察研究。
Impact of the SARS-CoV-2 (COVID19) pandemic on the morbidity and mortality of high risk patients undergoing surgery: a non-inferiority retrospective observational study.
机构信息
Department of Anaesthesiology and Critical Care, Bellvitge University Hospital, University of Barcelona, Hospitalet de Llobregat, carrer Feixa Llarga s/n, 08907, Barcelona, Spain.
Health Group, Neuroscience Program, Perioperative Physiopathology and Pain, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.
出版信息
BMC Anesthesiol. 2021 Nov 26;21(1):295. doi: 10.1186/s12871-021-01495-3.
BACKGROUND
During the COVID-19 crisis it was necessary to generate a specific care network and reconvert operating rooms to attend emergency and high-acuity patients undergoing complex surgery. The aim of this study is to classify postoperative complications and mortality and to assess the impact that the COVID-19 pandemic may have had on the results.
METHODS
this is a non-inferiority retrospective observational study. Two different groups of surgical patients were created: Pre-pandemic COVID and Pandemic COVID. Severity of illness was rated according to the Diagnosis-related Groups (DRG) score. Comparisons were made between groups and between DRG severity score-matched samples. Non-inferiority was set at up to 10 % difference for grade III to V complications according to the Clavien-Dindo classification, and up to 2 % difference in mortality.
RESULTS
A total of 1649 patients in the PreCOVID group and 763 patients in the COVID group were analysed; 371 patients were matched for DRG severity score 3-4 (236 preCOVID and 135 COVID). No differences were found in relation to re-operation (22.5 % vs. 21.5 %) or late admission to critical care unit (5.1 % vs. 4.5 %). Clavien grade III to V complications occurred in 107 patients (45.3 %) in the PreCOVID group and in 56 patients (41.5 %) in the COVID group, and mortality was 12.7 % and 12.6 %, respectively. During the pandemic, 3 % of patients tested positive for Covid-19 on PCR: 12 patients undergoing elective surgery and 11 emergency surgery; there were 5 deaths, 3 of which were due to respiratory failure following Covid-19-induced pneumonia.
CONCLUSIONS
Although this study has some limitations, it has shown the non-inferiority of surgical outcomes during the COVID pandemic, and indicates that resuming elective surgery is safe.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT04780594 .
背景
在 COVID-19 危机期间，有必要建立一个特定的护理网络，并将手术室重新改建为紧急和高重症患者的手术室，以收治正在接受复杂手术的患者。本研究的目的是对术后并发症和死亡率进行分类，并评估 COVID-19 大流行可能对结果产生的影响。
方法
这是一项非劣效性回顾性观察研究。创建了两组不同的手术患者：大流行前 COVID 组和大流行 COVID 组。根据诊断相关组（DRG）评分评估疾病严重程度。对两组和 DRG 严重程度匹配样本进行比较。根据 Clavien-Dindo 分类，III 至 V 级并发症的非劣效性设定为 10%以内，死亡率的非劣效性设定为 2%以内。
结果
在 PreCOVID 组中共有 1649 例患者，在 COVID 组中有 763 例患者，对 371 例 DRG 严重程度评分 3-4 的患者进行了匹配（236 例 PreCOVID 和 135 例 COVID）。两组在再次手术（22.5% vs. 21.5%）或重症监护病房迟入住（5.1% vs. 4.5%）方面无差异。PreCOVID 组中有 107 例（45.3%）患者发生 Clavien III 至 V 级并发症，COVID 组中有 56 例（41.5%）患者发生此类并发症，死亡率分别为 12.7%和 12.6%。在大流行期间，3%的患者经 PCR 检测新冠病毒阳性：12 例择期手术患者和 11 例急诊手术患者；有 5 例死亡，其中 3 例死于 COVID-19 引起的肺炎后的呼吸衰竭。
结论
尽管本研究存在一些局限性，但它表明 COVID-19 大流行期间手术结果无差异，表明恢复择期手术是安全的。
试验注册
Clinicaltrials.gov 标识符：NCT04780594。
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